1. Field of Invention
This invention relates generally to natural, organic, antifungal, and antibacterial topical cream formulations having superior moisturizing and water repellency performance for the prevention and elimination of common and sever diaper rash.
2. Discussion (Background of the Invention)
Historically diaper rash is believed to be a reaction of excrement, both solid and liquid, with the skin, causing irritation. Further, it is accepted within the industry that the rash causing agents in said excrement are from the acidic discharge of feces and urine creating a chemical burn that causes the skin to inflame. The counter to this acidic inflammation of the skin has been two fold. First, to create an impermeable barrier on the outer layer of the skin using petroleum based products such as petrolatum, and second, to employ amphoteric oxides that are insoluble in water but soluble in most acids thereby absorbing the acidic components and pulling them away from the skin.
One drawback to this petrolatum-amphoteric oxide approach is the limited absorption of the composition into the skin. Due to the high viscosity and highly mobile state of said compositions one finds that these compositions tend to spread throughout the region where diaper rash occurs rather than stay where (in the location) they were applied thereby spreading feces and urine along with it. Further these petroleum based products have limited, if any, absorption into the skin leaving a greasy residue to clean up after defecation.
A second drawback to the petrolatum-amphoteric oxide approach is the issue of moisture in the diaper region and the incorporation of said amphoteric oxides such as titanium oxide (TiO2) or zinc oxide (ZnO), both inorganic astringents at various concentrations ranging from 10 to 40%. While zinc oxide, titanium oxide, and other amphoteric astringents are soluble in acids, 95% of human urine is water. Due to this limited solubility, it is commonly accepted within the industry that simply increasing the amount of zinc oxide (for example) will supply enough oxide to absorb any and all acid generated. This approach in and of itself has a number of drawbacks, the first being the powderized nature of these oxides. In using such high concentrations, in some cases up to 40% by weight, the product leaves behind a chalky white film on the skin even after the product is removed. Further, with the availability of cheaper oxides, most of which are of a particle size of 100 nm or less (nano), using concentrations of up to 40% by weight can potentially cause inhalation issues.
In the case of sever diaper rash, when the typical astringent based methods fail a prescription such as a polyene antifungal medication (commonly known as Nystatin), or a miconazole nitrate blend, as in Vusion®, is employed which tend to be egregiously expensive and can be toxic. Such prescriptions in the U.S. can cost in excess of $200.00. This is certainly expensive for first world nations but unattainable by most second and third world nations that reside along the equator where the prevalence of these rashes is highest.
While a multitude of attempts to repel, inhibit, buffer, and/or neutralize the acidic environment of urine and feces have been made within the industry, none have addressed the flora contained in typical excrement. Babies, due to accelerated growth, urinate and defecate more frequently than do adults. It can be shown that infants from birth to about two months of age can urinate on average up to 12 times a day and 5 to 10 times a day, thereafter up to about age 2. Depending on the condition and severity thereof, it can further be shown that babies can defecate up to 8 times a day under sever abdominal distress conditions. Urine typically has a pH range of 4.6 to 8 and generally leaves the body containing numerous Gram negative bacteria that can release ammonia containing compounds upon the breakdown of Urea. Further, upon defecation infant feces carries with it a host of proteins, enzymes, ammonia, fatty acids, and intestinal bacteria and fungus.
Of the human gut flora there are approximately 1000 different species comprising bacteria, fungus, and protozoa. Said bacterial species include Bacteroides, Clostridium, Fusobacterium, Eubacterium, Ruminococcus, Peptococcus, Peptostreptococcus, and Bifidobacterium. It is estimated that about 99% of the bacteria living in the colon come from a mere 30 to 40 species and make up to 60% of the dry mass of feces. Of the fungi present, Candida, Saccharomyces, Aspergillus, and Penicillium are known.
The most common fungus excreted in feces is Candida albicans a commensal gut flora which comes from the upper or lower intestinal tract. Candida can be accompanied in babies with an infection of the mouth commonly referred to as thrush. Typical symptoms in the diaper region include a reddening of the infected area from the anus to the thighs, including the genitals, genital creases, and the abdomen. The rash typically begins with a softening and reddening of the tissue in the perineum region from a combination of bacteria, fungus, chemical irritation, and enzymatic degradation. Satellite pustules (small, raised, red circular areas), characteristic of Candida albicans infections, appear around the perimeter of the infected region. These satellite pustules are the defining difference between a Candida infection and a simple frictional rash whereas due to the overlapping of skin acting to protect the non exposed areas, said pustules are typically not present.
In the most severe cases of rash and contact dermatitis a prescription antifungal cream is often used. These prescriptions tend to be a topical corticosteroid preparation in the form of hydrocortisone, or a corticosteroid/antifungal combination such as hydrocortisone/miconazole. These prescriptions tend to be prohibitively expensive and not readily available over the counter.
Several solutions to these issues exist, however none claim to simultaneously solve all of these problems. What is needed is an over the counter, all natural, organic, antifungal, antibacterial cream having superior moisturizing and water repellency performance properties that absorb into the epidermis without spreading, thereby killing the rash causing fungus that causes diaper rash, and other skin irritation rashes. Further, none of the aforementioned compositions have demonstrated the ability to kill fungus or bacteria while creating an absorbed waterproof barrier to urine and feces.
Due to the superior water repellency, absorption into the skin, antibacterial and antifungal properties of the present formulation, a buffering, enzymatic inhibition, or a chelating system is not needed as the acid environment of urine and feces does not interact with the skin. Further because the formulation completely absorbs into the skin there is no messy, greasy white reside left on the skin to spread the feces nor is there a need to clean off said residue after defecation has occurred. Lastly, due to the antibacterial and antifungal nature of the formulation there is no need for artificial preservatives to insure freshness.
Therefore it is the object of this invention to solve one or more of these problems.